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Trial Title:
Preoperative PSMA PET/CT as Triage for ePLND in Patients Scheduled for RALP (PrePSMA)
NCT ID:
NCT06398613
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PSMA PET/CT
Description:
Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT)
will done preoperatively
Arm group label:
PrePSMA Arm B
Summary:
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal
staging in men with prostate cancer (PCa). The aim of this project is to determine if
preoperative prostate specific membrane antigen (PSMA) positron emission tomography
(PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa
patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
Detailed description:
Eligible for the study is patients scheduled for RALP and ePLND according to current
practice. Patients will be randomized between RALP and ePLND (Arm A) and PSMA PET/CT (arm
B). If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND
comcomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed.
Primary outcome measures:
Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years
after initiation of primary treatment (BCR ≥ 0.2 ng/ml).
Secondary outcome measures:
Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP
and initiation of salvage therapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Biopsy proven newly diagnosed adenocarcinoma of the prostate
- Indication for ePLND combined with RALP (Briganti 2019 nomogram risk >7%)
- Written informed consent
- No known allergies for PSMA tracer
Exclusion Criteria:
- History of prior diagnosed or treated PCa
- Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
- Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- If MRI shows distant metastasis to non-regional lymph nodes (M1a) or bone metastasis
(M1b) on MRI imaging
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
4950
Country:
Norway
Status:
Recruiting
Start date:
April 26, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
University Hospital, Akershus
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398613
